Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy (CONDOR)

Novartis

Status and phase: Active, not recruiting; Phase 3

Conditions: Proliferative Diabetic Retinopathy

Treatments: Biological: Brolucizumab 6 mg; Procedure: Panretinal photocoagulation laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT04278417

CRTH258D2301

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Full description

The study is an ongoing, Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (PRP) in subjects with Proliferative diabetic retinopathy (PDR). Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments:

• Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
• PRP: initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment (may split into 2-4 sessions) as needed up to Week 90. Visits occurred every 6 weeks throughout the study, regardless of treatment or not.

Enrollment: 689 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent must be obtained prior to participation
• Able to complete adequate fundus photographs and retinal images
• Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
• DM treatment stable for at least 3 months
• PDR diagnosis with no previous PRP treatment in the study eye

Exclusion criteria

• Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
• Presence of diabetic macular edema in the study eye
• Active infection or inflammation in the study eye
• Uncontrolled glaucoma (IOP greater than 25 mmHg)
• Intravitreal anti-VEGF treatment within 6 months
• Treatment with intraocular corticosteroids
• End stage renal disease requiring dialysis or kidney transplant
• Uncontrolled blood pressure
• Systemic anti-VEGF therapy at any time

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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689 participants in 2 patient groups

Brolucizumab 6 mg

Experimental group

Description:

Intra-vitreal injection. 3 x q6w loading injections, followed by q12w maintenance through Week 90

Treatment:

Biological: Brolucizumab 6 mg

Panretinal photocoagulation laser Arm

Active Comparator group

Description:

Initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Treatment:

Procedure: Panretinal photocoagulation laser